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Non-invasive Brain Stimulation

tDCS + TUS for Opioid Use Disorder

N/A
Recruiting
Led By Ciro R Estebanez, MD PhD
Research Sponsored by Case Western Reserve University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 to 85 years old.
Suffering from severe depression (with a score of >30 in the Beck Depression Inventory (BDI), PHQ-9≥10).
Must not have
History of unexplained fainting spells as self-reported.
History of brain surgery as self-reported.
Timeline
Screening 1 day
Treatment Varies
Follow Up 24 weeks
Awards & highlights

Summary

This trial will study whether transcranial Direct Current Stimulation (tDCS) + Transcranial Ultrasound (TUS) can help treat addiction in people with chronic pain who use opiates. The investigators think active stimulation will be better than fake stimulation.

Who is the study for?
This trial is for adults aged 18-85 with opioid use disorder (OUD) and chronic pain, who have been diagnosed according to DSM-5 criteria. Participants must consent to the study, live locally without relocation plans, and can't be on high doses of methadone. Excluded are pregnant individuals, those with a history of illegal stimulant use or certain neurological disorders, recent brain surgery patients, or those on new antiepileptic drugs.Check my eligibility
What is being tested?
The study tests if transcranial Direct Current Stimulation (tDCS) combined with Transcranial Ultrasound (TUS) helps treat addiction in people with OUD and chronic pain. It compares active stimulation's effects on drug use reduction and psychosocial improvement against sham (fake) treatments.See study design
What are the potential side effects?
While not explicitly listed in the provided information, tDCS and TUS may cause mild side effects such as headache, scalp discomfort at the site of electrode application for tDCS; TUS might include local discomfort or skin irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 85 years old.
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I have severe depression based on standard tests.
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I currently have cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had fainting spells that doctors couldn't explain.
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I have had brain surgery.

Timeline

Screening ~ 1 day
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 1 day for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in drug use from baseline.
Secondary outcome measures
15-item Barrett Impulsivity scale
Changes in pain as measured by the Visual Analog Scale (VAS)
Changes in the Verbal Rating Scale (VRS) for Pain
+13 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active (tDCS) + Active TUSActive Control1 Intervention
Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS)
Group II: Sham (tDCS) + Sham TUSPlacebo Group1 Intervention
Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Highland Instruments, Inc.Industry Sponsor
10 Previous Clinical Trials
523 Total Patients Enrolled
Case Western Reserve UniversityLead Sponsor
300 Previous Clinical Trials
246,581 Total Patients Enrolled
Ciro R Estebanez, MD PhDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center/ Case Western Reserve University

Media Library

Optimization of NIBS for Treatment of Addiction (Non-invasive Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04379115 — N/A
Opioid Use Disorder Research Study Groups: Sham (tDCS) + Sham TUS, Active (tDCS) + Active TUS
Opioid Use Disorder Clinical Trial 2023: Optimization of NIBS for Treatment of Addiction Highlights & Side Effects. Trial Name: NCT04379115 — N/A
Optimization of NIBS for Treatment of Addiction (Non-invasive Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04379115 — N/A
Opioid Use Disorder Patient Testimony for trial: Trial Name: NCT04379115 — N/A
~0 spots leftby Aug 2024